Cleared Traditional

K162952 - C.T.M. Mobility Scooter

K162952 is the FDA 510(k) clearance for C.T.M. Mobility Scooter by Chien TI Enterprise Co., Ltd.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K162952 · Chien TI Enterprise Co., Ltd. · Physical Medicine device
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May 2017
Decision
191d
Days
Class 2
Risk

K162952 is an FDA 510(k) clearance for the C.T.M. Mobility Scooter. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Chien TI Enterprise Co., Ltd. (New Taipei City, Hsin Chuang District, TW). The FDA issued a Cleared decision on May 3, 2017 after a review of 191 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Chien TI Enterprise Co., Ltd. devices

Submission Details

510(k) Number K162952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date May 03, 2017
Days to Decision 191 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 115d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 80
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K162952.
C.T.M Mobility Scooter
K181344 · Chien TI Enterprise Co., Ltd. · Dec 2018
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
K172440 · Dongguan Prestige Sporting Goods., Ltd. · Jul 2018
Lite
K172409 · Tzora Active Systems , Ltd. · May 2018
HEARTWAY Power Mobility Scooter
K151656 · Heartway Medical Products Co., Ltd. · Nov 2015
HEARTWAY Power Mobility Scooter
K150998 · Heartway Medical Products Co., Ltd. · Sep 2015
HEARTWAY Power Mobility Scooter, BRIO S19
K150987 · Heartway Medical Products Co., Ltd. · Sep 2015